Pharmacovigilance Solutions . . .Dr John Marr MB BS MSc FRSM

I provide a wide spectrum of pharmacovigilance services for small to medium pharma companies, from Consultant Medical Advisor up to Intermim CMO/Medical Director level. With special expertise in start-up companies and medical advisor support in early Phase I/II clinical trials, I can enter your program at any stage.
I serve as a medical expert to the team, supporting Global Safety in the management of safety signals, risk management activities and benefit-risk assessments for assigned products.
I take responsibility for the conduct of safety monitoring, and provide accountable input for all product-related safety decisions.

Applicable tasks will vary for each company, but I am able to take responsibility for:

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The planning, preparation, writing and review of portions of aggregate reports

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Organization and direct liaison activities with affiliates and other partners

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Supporting and providing oversight to safety in clinical trials to review and provide input on study protocols, statistical analysis plans, safety content for filings, and review of safety tables, figures and listings from clinical studies

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Supporting activities related to new drug applications and other regulatory filings